Drug delivery device with removable pods and related pods, methods and systems

Abstract

A drug delivery device with removable pods is described and related pods methods and systems. The drug delivery device comprises a plurality of receptacles, each receptacle configured to accept a corresponding drug pod, wherein each receptacle comprises: a recess configured to accept a protrusion in the corresponding drug pod, or a protrusion configured to insert in a recess in the corresponding drug pod. The corresponding drug pod comprises a shell, made of an impermeable polymer, having a first base comprising an opening configured to allow delivery of a drug, a second base, a lateral surface, a protrusion attached to, and extending away from, the lateral surface, or a recess in the lateral surface.

Description

[0001] Cross References to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 487,415, docket No. P2026-USP, entitled "Drug Delivery Device with Removable Pods," filed April 19, 2017, the contents of which are incorporated herein by reference in their entirety .

[0003] Government Grant Statement

[0004] This invention was made with government support under Grant No. R44MH110161 awarded by the National Institutes of Health. The government has certain rights in this invention. technical field

[0005] The present disclosure relates to drug delivery devices and drug release using the same, and in particular to drug delivery devices having removable pods and related pods, compositions, methods and systems. Background technique

[0006] Over the past few decades, a variety of drug delivery devices have been developed for both local and systemic delivery of drugs to vaginal, rectal or other tissues.

[0007] Despite efforts...

Examples

Embodiment 1

[0146] Example 1: Drug Delivery Efficacy of a Prior Art IVR System Without Removable Pods

[0147] The potency of IVR-released TDF-FTC was demonstrated in repeated challenge primate transmission studies.

[0148] The trial consisted of an open-label crossover design in which six participants were sequentially administered TDF pod-IVR for 7 days followed by TDF-FTC pod-IVR with a washout period of at least 14 days between each treatment period. Clinically eligible women returned to the clinic after cessation of menstruation for follow-up IVR insertions (Visit 1, TDF TVR; Visit 5, TDF-FTC IVR). Women return for Visit 2 (TDF IVR) or Visit 6 (TDF-FTC IVR) on day 2 (±1 day) after IVR insertion and follow-up on day 7 (±1 day) when IVR is removed 3 (TDF IVR) or follow-up 7 (TDF-FTC IVR). At follow-up 3 / 7, vaginal biopsies were obtained and IVRs were collected. Final tissue samples were reported as ng / mg or fmol / mg after normalization to net biopsy or Dacron swab weight, respecti...

Embodiment 2

[0151] Example 2: Drug delivery system for contraception and treatment of genital herpes with the present invention that does not contain removable pods Skilled IVR

[0152] The following sections describe preliminary data on pod-in-ring prior art IVR, such as that shown in Figure 13, and in particular: the TDF-FTC ring for HIV PrEP; the ETG-EE ring for contraception; ACV ring in genital herpes.

[0153] Preliminary data for TDF-FTC pod-IVR release evaluated in clinical safety and PK studies under IND No. 123099 sponsored by Auritec in a 7-day clinical trial API (TDF-FTC) IVR. The results are shown in Figure 12, as described above in this disclosure.

[0154] Figure 15 shows a graph of ETG-EE release: ETG (1510); EE (1505). The ring-in-pods of this example deliver etonogestrel (ETG) and estradiol (EE). The silicone pod IVR contained two EE pods of 16 mg API each (32 mg drug per ring), and two ETG pods of 10 mg API each (20 mg drug per ring). The median ETG CVL level ...

Embodiment 3

[0156] Example 3: Using a prior art IVR system without removable pods, in blood and cervicovaginal douches Clinical research on anti-HSV activity in (cervicovaginal lavage, CVL)

[0157] Clinical studies were performed using a prior art IVR without removable pods, such as that described in FIG. 13 .

[0158] Six HSV+ women with recurrent genital HSV switched their daily oral valacyclovir suppression to acyclovir based on a phased clinical trial of an IND (No 108,536) release ring for the treatment and prevention of genital herpes. Cyclovir (ACV) IVR for 7 days (n=3) or 14 days (n=3). Tolerability and PK were assessed, and antiviral activity in cervicovaginal lavage (CVL) samples was correlated to drug levels in the samples. This first-in-human study in women with ACV IVR demonstrates that reproductive tract ACV levels similar to oral valacyclovir can be delivered without systemic absorption. The ring was well tolerated, with no colposcopy findings or significant changes ...

[0001] Cross References to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 487,415, docket No. P2026-USP, entitled "Drug Delivery Device with Removable Pods," filed April 19, 2017, the contents of which are incorporated herein by reference in their entirety .

[0003] Government Grant Statement

[0004] This invention was made with government support under Grant No. R44MH110161 awarded by the National Institutes of Health. The government has certain rights in this invention. technical field

[0005] The present disclosure relates to drug delivery devices and drug release using the same, and in particular to drug delivery devices having removable pods and related pods, compositions, methods and systems. Background technique

[0006] Over the past few decades, a variety of drug delivery devices have been developed for both local and systemic delivery of drugs to vaginal, rectal or other tissues.

[0007] Despite efforts...

Examples

Embodiment 1

[0146] Example 1: Drug Delivery Efficacy of a Prior Art IVR System Without Removable Pods

[0147] The potency of IVR-released TDF-FTC was demonstrated in repeated challenge primate transmission studies.

[0148] The trial consisted of an open-label crossover design in which six participants were sequentially administered TDF pod-IVR for 7 days followed by TDF-FTC pod-IVR with a washout period of at least 14 days between each treatment period. Clinically eligible women returned to the clinic after cessation of menstruation for follow-up IVR insertions (Visit 1, TDF TVR; Visit 5, TDF-FTC IVR). Women return for Visit 2 (TDF IVR) or Visit 6 (TDF-FTC IVR) on day 2 (±1 day) after IVR insertion and follow-up on day 7 (±1 day) when IVR is removed 3 (TDF IVR) or follow-up 7 (TDF-FTC IVR). At follow-up 3 / 7, vaginal biopsies were obtained and IVRs were collected. Final tissue samples were reported as ng / mg or fmol / mg after normalization to net biopsy or Dacron swab weight, respecti...

Embodiment 2

[0151] Example 2: Drug delivery system for contraception and treatment of genital herpes with the present invention that does not contain removable pods Skilled IVR

[0152] The following sections describe preliminary data on pod-in-ring prior art IVR, such as that shown in Figure 13, and in particular: the TDF-FTC ring for HIV PrEP; the ETG-EE ring for contraception; ACV ring in genital herpes.

[0153] Preliminary data for TDF-FTC pod-IVR release evaluated in clinical safety and PK studies under IND No. 123099 sponsored by Auritec in a 7-day clinical trial API (TDF-FTC) IVR. The results are shown in Figure 12, as described above in this disclosure.

[0154] Figure 15 shows a graph of ETG-EE release: ETG (1510); EE (1505). The ring-in-pods of this example deliver etonogestrel (ETG) and estradiol (EE). The silicone pod IVR contained two EE pods of 16 mg API each (32 mg drug per ring), and two ETG pods of 10 mg API each (20 mg drug per ring). The median ETG CVL level ...

Embodiment 3

[0156] Example 3: Using a prior art IVR system without removable pods, in blood and cervicovaginal douches Clinical research on anti-HSV activity in (cervicovaginal lavage, CVL)

[0157] Clinical studies were performed using a prior art IVR without removable pods, such as that described in FIG. 13 .

[0158] Six HSV+ women with recurrent genital HSV switched their daily oral valacyclovir suppression to acyclovir based on a phased clinical trial of an IND (No 108,536) release ring for the treatment and prevention of genital herpes. Cyclovir (ACV) IVR for 7 days (n=3) or 14 days (n=3). Tolerability and PK were assessed, and antiviral activity in cervicovaginal lavage (CVL) samples was correlated to drug levels in the samples. This first-in-human study in women with ACV IVR demonstrates that reproductive tract ACV levels similar to oral valacyclovir can be delivered without systemic absorption. The ring was well tolerated, with no colposcopy findings or significant changes ...

Images